Condition category
Nervous System Diseases
Date applied
12/10/2015
Date assigned
22/10/2015
Last edited
12/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study is performed in patients having cardiac (heart) surgery with the use of a heart-and-lung machine. Blood supply to the brain is normally regulated by a mechanism called 'cerebral autoregulation'. Cerebral autoregulation means that the body preserves blood supply to the brain despite wide variations in blood pressure. A way of assessing blood supply to the brain is measuring the oxygen content of a small part of the brain tissue using near-infrared spectroscopy. This is a non-invasive method where two adhesive pads are placed on the patient's forehead. These pads send out light at a frequency close to the infrared part of the electromagnetic spectrum. This light can penetrate the skull and is reflected by the brain tissue. By analysing the reflected light, the oxygen saturation (i.e. the amount of oxygen present) of a small portion of the brain can be measured. Recent studies investigated the effects of different blood-pressure-increasing medications on the cerebral oxygenation (oxygen levels in the brain) and found that after a dose of the drug phenylephrine, blood pressure was raised, but cerebral oxygenation decreased. A possible mechanism for this could be that phenylephrine slightly increases the resistance of blood vessels to the brain and thus decreasing the blood flow; this potentially leads to a decrease in the oxygenation of brain tissue. In this study we want to investigate this hypothesis further by performing several blood-pressure-increasing manoeuvres in patients connected to a heart-and-lung machine during cardiac surgery. These include administration of two different substances widely used in standard care of anaesthesia to raise blood pressure (phenylephrine and vasopressin) and a increment (increase) in the heart-and-lung machine pump flow (to simulate a rise in cardiac output). These different manoeuvres will all raise blood pressure, but might have different effects on cerebral oxygenation. The results of this study will help to get a better understanding of physiological (normal) mechanisms that control blood supply to the brain.

Who can participate?
Adults aged 18-70 having cardiac surgery requiring a heart-and-lung machine.

What does the study involve?
During surgery, the blood pressure of all the participants are raised in three different ways in a randomized order. The first method of raising blood pressure is α1-mediated, with phenylephrine, while CPB (cardiopulmonary bypass)-flow is clamped. The second method is non-α1-mediated, with vasopressin while CPB-flow remains unchanged. The third method involve increasing CPB-flow. Cerebral oxygenation and arterial blood pressure is measured for each participant before and after each method is applied.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Academic Medical Center AMC (Netherlands)

When is the study starting and how long is it expected to run for?
January 2010 to June 2013

Who is funding the study?
Academic Medical Center, AMC Amsterdam (Netherlands)

Who is the main contact?
Mr Niek Sperna Weiland

Trial website

Contact information

Type

Scientific

Primary contact

Mr Niek Sperna Weiland

ORCID ID

http://orcid.org/0000-0003-1305-1846

Contact details

Academic Medical Center
Department of Anesthesiology
Meibergdreef 9
Amsterdam Zuidoost
1105 AZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol revision 2.3; nov 23, 2009. NL29879.018.09. MEC 09/280.

Study information

Scientific title

Cerebral oxygenation during changes in vascular resistance and flow in patients on cardiopulmonary bypass: a randomized cross over trial

Acronym

Study hypothesis

Phenylphrine causes α1-receptor mediated cerebral vasoconstriction

Ethics approval

Medisch Ethische Toetsingscommissie Academisch Medisch Centrum, ref: 09/280

Study design

Single center interventional study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Participant information available in Dutch only. Not available in web format, please use the contact details below to request a copy of the patient information sheet.

Condition

Physiology of brain perfusion.

Intervention

During the cardiopulmonary bypass-phase of cardiac operations, when the patients were hemodynamically stable and a CPB-flow was 2.6 L•m-2•min-1 subjects underwent three interventions in randomized order. During these interventions no other hemodynamic interventions were performed.
1. Mean arterial blood pressure (MABP) was raised by increasing CPB-flow by 0.5 L•m-2•min-1 for five minutes
2. MABP was raised ≈15 mmHg by an α1-mediated increase in SVR with a PE bolus of 50-150 µg while CPB flow remained unaltered at 2.6 L•m-2•min-1
3. MABP was increased ≈15 mmHg by a V1-receptor mediated increase in SVR with a VP bolus of 0.1 - 0.4 IU while CPB flow remained unaltered at 2.6 L•m-2•min-1

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Cerebral oxygenation before and after each intervention.

Secondary outcome measures

Arterial blood pressure before and after each intervention.

Overall trial start date

01/01/2010

Overall trial end date

14/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-70 years
2. Patients scheduled for elective cardiac surgery (CABG, aortic valve repair, mitral valve repair or combinations of the former), using mil hypothermic cardiopulmonary bypass.
3. Written informed consent present

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Age ≤18 years
2. Emergency operations
3. Brain pathology in history (CVA)
4. Severe carotid artery stenosis (if no data is available, an echo-Doppler will be performed by the anesthesiologist after induction of anesthesia, prior to surgery)
5. Severe COPD
6. Absent informed consent
7. SaO2<90% at room temperature
8. Diabetes
9. Kidney failure

Recruitment start date

23/03/2010

Recruitment end date

14/06/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center AMC
Meibergdreef 9
Amsterdam-Zuidoost
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Center AMC

Sponsor details

Meibergdreef 9
Amsterdam Zuidoost
1105AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Center, AMC Amsterdam (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

31/12/2015

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes